Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT04661956
Status:
UNKNOWN
Last Update Posted:
2021-10-15
First Post:
2020-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in The Pulmonary Periphral Nodule
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013525', 'term': 'Surgical Instruments'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a prospective multicenter random control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-12-09', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnotic yield', 'timeFrame': 'six months', 'description': 'Percentage of definitive pathological diagnosis by transbronchial cryobiopsy'}], 'secondaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': 'one week', 'description': 'Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transbronchial Cryobiopsy', 'Diagnostic Yield', 'Safety', 'Pulmonary Periphral Nodule'], 'conditions': ['Diagnosis', 'Complication Rate']}, 'descriptionModule': {'briefSummary': 'Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety.', 'detailedDescription': 'Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety. This is a multi-center prospective randomized control trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patients are admitted as Pulmonary Periphral Nodule, while undefined after thorough history collection, laboratory examination and radiological data.\n2. The longest diameter of the Pulmonary Periphral Nodule is less than 30mm in HRCT.\n3. The Pulmonary Periphral Nodule can be detected by radial-EBUS\n4. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.\n5. Routine blood test, ECG examination, coagulation function, chest HRCT have been completed.\n\nExclusion Criteria:\n\n1. The longest diameter of the Pulmonary Periphral Nodule is more than 30mm.\n2. The Pulmonary Periphral lesions cannot be detected by the radial endobronchial ultrasound.\n3. The clinical examinations mentioned above are not completed. The patient cannot endure or does not agree the procedure'}, 'identificationModule': {'nctId': 'NCT04661956', 'briefTitle': 'The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in The Pulmonary Periphral Nodule', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Institute of Respiratory Disease'}, 'officialTitle': 'The Diagnostic Yield and Safety of Transbronchial Cryobiopsy Under The Guidance of The Endobronchial Ultrasound in The Pulmonary Periphral Nodule: A Multicenter Prospective Random Control Trial', 'orgStudyIdInfo': {'id': '20200914'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transbronchial cryobiopsy', 'description': 'Transbronchial cryobiopsy was performed in the patiens of pulmonary peripheral nodule', 'interventionNames': ['Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)']}, {'type': 'OTHER', 'label': 'Transbronchial lung biopsy', 'description': 'Transbronchial lung biopsy was performed in the patiens of pulmonary peripheral nodule', 'interventionNames': ['Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)']}], 'interventions': [{'name': 'Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)', 'type': 'PROCEDURE', 'description': 'Transbronchial lung biopsy by cryoprobe or by forcep', 'armGroupLabels': ['Transbronchial cryobiopsy', 'Transbronchial lung biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '233004', 'city': 'Bengbu', 'state': 'Anhui', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Wei', 'role': 'CONTACT', 'email': 'bbmcliwei@126.com', 'phone': '13965282263'}, {'name': 'Gong Beilei', 'role': 'CONTACT', 'email': 'huihuang889@sina.com', 'phone': '13155220218'}], 'facility': 'The First Affiliated Hospital of Bengbu Medical College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '230003', 'city': 'Hefei', 'state': 'Anhui', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lv Liping, bachelor', 'role': 'CONTACT', 'email': 'lvliping1759@sina.com', 'phone': '13956954712'}], 'facility': 'AnHui Chest Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hou Gang', 'role': 'CONTACT', 'email': 'hou_gang@163.com', 'phone': '13840065481'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '361021', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ke Mingyao, bachelor', 'role': 'CONTACT', 'email': '13860166866@126.com', 'phone': '13860166866'}], 'facility': 'Xiamen Second Hospital', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '730030', 'city': 'Lanzhou', 'state': 'Gansu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wan Yixin', 'role': 'CONTACT', 'email': '1019374153@qq.com', 'phone': '13919267218'}, {'name': 'Wu Fanqi', 'role': 'CONTACT', 'email': '173616886@qq.com', 'phone': '13919236833'}], 'facility': 'Lanzhou University Second Hospital', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '730099', 'city': 'Lanzhou', 'state': 'Gansu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yue Hongmei', 'role': 'CONTACT', 'email': 'Yuehongme@csco.org.cn', 'phone': '13893265368'}, {'name': 'Pu Jiayuan', 'role': 'CONTACT', 'email': 'pujiayuan@hotmail.com', 'phone': '13883139643'}], 'facility': 'The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Jing, doctor', 'role': 'CONTACT', 'email': '472522080@qq.com', 'phone': '13825009393'}, {'name': 'Luo Shaohua', 'role': 'CONTACT'}], 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liao Huai, master', 'role': 'CONTACT', 'email': 'liaohuai1208@hotmail.com', 'phone': '020-87755766-8171'}], 'facility': 'The First Affiliated Hospital Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liu Laiyu, doctor', 'role': 'CONTACT', 'email': 'liulaiyu@126.com', 'phone': '13632102245'}], 'facility': 'Southern Medical University Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518036', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xu Ping, doctor', 'role': 'CONTACT', 'email': '799721206@qq.com', 'phone': '0755-83923333'}, {'name': 'Song WD, doctor', 'role': 'CONTACT', 'email': 'SongWD123@hotmail.com', 'phone': '0755-83923333'}], 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '518106', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Long Fa, master', 'role': 'CONTACT', 'email': 'longfa_923@163.com', 'phone': '13651472098'}], 'facility': "Shenzhen Guangming New District People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhang Xiaoju, doctor', 'role': 'CONTACT', 'email': '15837101166@163.com', 'phone': '0371-65580653'}, {'name': 'Zhang Quncheng, master', 'role': 'CONTACT', 'email': 'zcc_0813@126.com', 'phone': '0371-65580330'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430014', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hu Yi, master', 'role': 'CONTACT', 'email': 'huyi_pub@163.com', 'phone': '13995618974'}], 'facility': 'The Central Hospital Of WuHan', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430015', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhang Jixian', 'role': 'CONTACT', 'email': 'jxzhang1607@163.com', 'phone': '13377897297'}], 'facility': 'Hubei Provincial Hospital of Integrated Chinese & Western Medicine', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410005', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liu Zhiguang, master', 'role': 'CONTACT', 'email': 'liuzhiguang0404@126.com', 'phone': '0731-83928074'}], 'facility': "People's Hospital of Hunan Province", 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Huaping, doctor', 'role': 'CONTACT', 'email': 'lyhuaping@aliyun.com', 'phone': '13973129956'}], 'facility': 'XiangYa Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ding Ming', 'role': 'CONTACT', 'email': 'maolading_527@sina.com', 'phone': '18951610130'}], 'facility': 'Zhongda Hospital Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '330209', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xu Fei', 'role': 'CONTACT', 'email': '532712825@qq.com', 'phone': '13870877117'}, {'name': 'Zou Meihong', 'role': 'CONTACT', 'email': 'zoumh197011@163.com', 'phone': '13870969460'}], 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sun Jiayuan, master', 'role': 'CONTACT', 'email': 'jysun1976@163.com', 'phone': '18017321598'}, {'name': 'Chen Junxiang', 'role': 'CONTACT'}], 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gu Ye, master', 'role': 'CONTACT', 'email': 'drsymons@outlook.com', 'phone': '13817624060'}, {'name': 'Yang Li', 'role': 'CONTACT'}], 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710010', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhou Yong, master', 'role': 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'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Feng, bachelor', 'role': 'CONTACT', 'email': 'piaopiaogou@163.com', 'phone': '0573-82082937'}], 'facility': 'The First Hospital of Jiaxing', 'geoPoint': {'lat': 30.7522, 'lon': 120.75}}], 'centralContacts': [{'name': 'Xiaobo Chen, Doctor', 'role': 'CONTACT', 'email': 'xiaobo-win@163.com', 'phone': '+8613751721744'}, {'name': 'Shiyue Li, master', 'role': 'CONTACT', 'email': 'lishiyue@188.com', 'phone': '8620-83062896'}], 'overallOfficials': [{'name': 'Shiyue Li, master', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ShiYue Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Guangzhou Institute of Respiratory Disease', 'investigatorFullName': 'ShiYue Li', 'investigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'}}}}